Radially compressed self-sealing septum

ABSTRACT

A septum used for sealing an opening formed in a neck of a container, the septum includes a top septum member that fits over the outside of the opening in the container and a bottom radial septum member structurally connected below the top septum to seal inside the neck of the container.

FIELD OF THE INVENTION

[0001] This invention relates generally to septums for containers and,in particular embodiments, to a septum for a vial that utilizes aradially compressed self-sealing septum.

BACKGROUND OF THE INVENTION

[0002] Pharmaceutical vials are used to hold liquid medications such asinsulin for later administration to a patient. Traditionally, thesevials include a lid, having a layer of septum to seal in the contents ofthe vial. Medication is generally extracted from the vial by piercingthe septum with a sharp point such as a hypodermic needle.

[0003] Typically, the septum is fixed onto an open end of the vial andis secured by a fitted metal collar that covers the septum. The fittedmetal collar is crimped to conform to the open end of the vial and tosecure the septum in place. A portion of the collar includes an openingto expose the septum beneath and to allow access for a needle to piercethe septum as described above. The septum layer is generally intended tobe resealing to prevent the contents of the vial to leak out after theneedle is withdrawn. However, in many instances leakage from the piercedseptum layer does occur after the removal of the needle. Furthermore,gaps caused by the piercing of the septum may contribute to contaminantsentering into the vial.

SUMMARY OF THE DISCLOSURE

[0004] It is an object of an embodiment of the present invention toprovide a radially compressed self-sealing septum, which obviates forpractical purposes, the above mentioned limitations.

[0005] According to an embodiment of the invention, a septum used forsealing an opening formed in a neck of a container includes a top septummember that fits over the outside of the opening in the container, and abottom radial septum member structurally connected below the top septummember to seal inside the neck of the container. The bottom radialseptum member has an upper portion, a lower portion, and a radial middlesection. Preferably, the radial middle section has a diameter greaterthan the upper and lower portion of the bottom radial septum member tocreate compression against the interior of the container.

[0006] In a further embodiment of the present invention, the lowerportion of the bottom radial septum member has a concave sphericalgeometry. It is the concave spherical geometry of the lower portion ofthe bottom radial septum member that prevents the septum from bowing outwhen in a compressed state. Furthermore, the septum is composed of aself-sealing septum material.

[0007] In an alternative embodiment of the present invention, a closuremay be used for sealing an opening in a container. The closure includesa neck of a container, a radially compressed self-sealing septum whichseals the neck of the container, a collar fitted over the septum andneck of the container to secure the septum in place.

[0008] Other features and advantages of the invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings which illustrate, by way of example,various features of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] A detailed description of embodiments of the invention will bemade with reference to the accompanying drawings, wherein like numeralsdesignate corresponding parts in the several figures.

[0010]FIG. 1 is an enlarged cross-sectional side view of the septum andvial, in accordance with an embodiment of the present invention;

[0011]FIG. 2 is an enlarged cross-sectional side view of the septum andvial in accordance with the embodiment shown in FIG. 1;

[0012]FIG. 3 is an enlarged cross-sectional view of the septum inaccordance with the embodiment shown in FIG. 1;

[0013]FIG. 4 is an enlarged perspective bottom view of the septum inaccordance with the embodiment shown in FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] As shown in the drawings for purposes of illustration, theinvention is embodied in a radially compressed self-sealing septum. Inpreferred embodiments of the present invention, a septum having a topseptum member structurally connected to a bottom radial septum member,and is used to seal a vial, or the like, to contain fluids, such asmedications, drugs, vitamins, vaccines, peptides or the like. Preferredembodiments of the vial are made out of glass. However, alternativeembodiments of the vial may be formed from plastic, metal, ceramic,composite, laminates, or the like.

[0015] Preferred embodiments of the present invention include a topseptum member structurally connected above a bottom radial septummember. The bottom radial septum member is inserted into a vial, or thelike, to seal the contents within. The bottom radial septum memberincludes a radial middle portion of a large diameter which becomescompressed when inserted within the vial, or the like, having a smallerdiameter. This compression creates a self-sealing effect on the entirebottom radial septum, specifically allowing a puncture from a hypodermicneedle, or the like, to self-seal.

[0016]FIGS. 1 and 2 illustrate a radially self-sealing septum 10 andcontainer 12 in accordance with a first embodiment of the presentinvention. The radially self-sealing septum 10 includes a top septummember 14, and a bottom radial septum member 16.

[0017] In preferred embodiments, the top septum member 14 serves as aclosure first for the opening in the container (for example, a vial).The top septum member 14 is generally external to the container and iscomposed of an elastomer type material such as but not limited torubber, or the like, that is capable of being pierced by a sharp objectsuch as a hypodermic needle, or the like, and has the ability toself-seal when in a compressed state. In alternative embodiments, it maybe necessary for the top septum member 14 to be composed of a differentmaterial or a combination of materials such as silicone, bromobutyl,natural synthetic isoprene, nitrile, ethylene propylene diene monomers,or the like, to prevent a damaging interaction between the septummaterial and the fluids within the container.

[0018] In preferred embodiments, the bottom radial septum member 16 isstructurally connected below the top septum member 14. An upper portion18 of the bottom radial septum member is attached to the top septummember 14, where a lower portion 20 of the bottom radial septum member16 is unattached and is within the container when the septum 10 is inuse. The bottom radial septum member 16 includes a radial middle section22 having a diameter larger than the top 18 and lower portion 20 of thebottom radial septum member 16, but similar to the top septum 14. Inalternative embodiments, the diameter of the radial middle section 22may vary depending on the type of container used, and may exceed thediameter of the top septum. However, the diameter of the radial middlesection 22 will exceed the diameter between the interior walls 24 of thecontainer. The large diameter of the radial middle section 22 of thebottom radial septum member 16 extends outwardly and becomes compressedby the interior walls 24 of the container when the bottom radial septummember 16 is inserted into the container. Consequently, the compressioncauses the bottom radial septum member 16 to self-seal when a hypodermicneedle, or the like, is withdrawn.

[0019]FIGS. 3 and 4 illustrate the self-sealing septum 10 in accordancewith an embodiment of the present invention that utilizes the septumshown in FIGS. 1 and 2. In preferred embodiments, the self-sealingseptum 10 includes a bottom radial septum member 16 having a lowerportion 20 with a concave spherical geometry. The lower portion 20 ofthe bottom radial septum member 16 is spherically indented to preventthe bottom radial septum member 16 from bowing out when it is in acompressed state, therefore maintaining its ability to self-seal. Inalternative embodiments, the lower portion 20 of the bottom radialseptum member 16 may differ in its geometry to adapt to varying degreesof compression.

[0020] While the description above refers to particular embodiments ofthe present invention, it will be understood that many modifications maybe made without departing from the spirit thereof. The accompanyingclaims are intended to cover such modifications as would fall within thetrue scope and spirit of the present invention.

[0021] The presently disclosed embodiments are therefore to beconsidered in all respects as illustrative and not restrictive, thescope of the invention being indicated by the appended claims, ratherthan the foregoing description, and all changes which come within themeaning and range of equivalency of the claims are therefore intended tobe embraced therein.

What is claimed is:
 1. A septum used for sealing an opening formed in aneck of a container, the septum comprising: a top septum member thatfits over the outside of the container forming an opening; and a bottomradial septum member structurally connected below the top septum to sealinside the neck of the container.
 2. The septum of claim 1, wherein thebottom radial septum member has an upper portion and a lower portion,and wherein the upper portion of the bottom radial septum member isstructurally connected to the top septum.
 3. The septum of claim 2,wherein the bottom radial septum member has a radial middle section, andwherein the radial middle section has a diameter greater than the upperand lower portion of the bottom radial septum member to createcompression against the interior of the container.
 4. The septum ofclaim 2, wherein the lower portion of the bottom radial septum memberhas a concave spherical geometry, and wherein the concave sphericalgeometry of the bottom radial septum member lower portion prevents theseptum from bowing out when in a compressed state.
 5. The septum ofclaim 1, wherein the septum is composed of a self-sealing septummaterial.